Abstract
Purpose
Treatment of patients with chronic low back pain (CLBP) aims to reduce disability, improve functional capacity, and participation. Time contingent prescription of analgesics is a treatment modality in CLBP. The impact of analgesics on functional capacity is unknown. Aim of the study was to explore the effect of analgesics on functioning measured by functional capacity evaluation, and self-reported disability in patients with CLBP.
Methods
Explorative Randomized Placebo-Controlled Clinical Trial was performed in an outpatient pain rehabilitation setting on patients waiting for rehabilitation. Included patients had low back pain lasting >3 months, visual analogue scale worst pain ≥4.0 cm, and age >18 years. Outcome measures before (T0) and after treatment (T1): functional capacity, pain intensity, Roland Morris Disability Questionnaire. T1: global perceived pain relief. Patient characteristics and psychological questionnaires were assessed. Fifty patients were included in this study and were randomly assigned to 2 weeks treatment or placebo. Treatment: acetaminophen/tramadol 325 mg/37.5 mg per capsule. Dose: maximum acetaminophen 1,950 mg and tramadol 225 mg per day; treatment and placebo titrated identically. Compliance and side-effects were monitored. Treatment effects between groups over time were compared.
Results
One patient (treatment group) was lost to follow-up. Forty-nine patients remained in the study. Treatment effects in primary outcomes did not differ significantly between groups. A subgroup of 10 (42 %) patients (treatment group) reported global pain relief (responders) who reduced self-reported disability (p < 0.05). Responders had significantly lower catastrophizing scores.
Conclusion
Overall treatment effects were small and non-significant. A subgroup, however, reported improved functioning as a result of treatment. Responders had lower catastrophizing scores.
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References
Truchon M (2001) Determinants of chronic disability related to low back pain: towards an integrative biopsychosocial model. Disabil Rehab 23:758–767
Borenstein DG (2001) Epidemiology, etiology, diagnostic evaluation, and treatment of low back pain. Curr Opin Rheumatol 13:128–134
WHO (2001) International classification of functioning, disability and health (ICF). World Health Organization, Geneva
Linton SJ (2000) A review of psychological risk factors in back and neck pain. Spine 25:1148–1156
Schiphorst Preuper HR, Reneman MF, Boonstra AM, Dijkstra PU, Versteegen GJ, Geertzen JHB, Brouwer S (2009) Relationship between psychological factors and performance-based and self-reported disability in chronic low back pain. Eur Spine J 17:1448–1456
NHG-Standaard aspecifieke lagerugpijn (Dutch standard low-back pain) (2005):M54. (Dutch). Huisarts en Wetenschap
Reig E (2002) Tramadol in musculoskeletal pain-a survey. Clin Rheumatol 21:S9–11 discussion S11-2
Ruoff GE, Rosenthal N, Jordan D, Karim R, Kamin M (2003) Tramadol/acetaminophen combination tablets for the treatment of chronic lower back pain: a multicenter, randomized, double-blind, placebo-controlled outpatient study. Clin Ther 25:1123–1141
Gross DP (2006) Are functional capacity evaluations affected by the patient’s pain? Curr Pain Headache Rep 10:107–113
Gross DP, Bhambhani Y, Haykowsky MJ, Rashiq S (2008) Acute opioid administration improves work-related exercise performance in patients with chronic back pain. J Pain 9:856–862
Brouwer S, Reneman MF, Dijkstra PU, Groothoff JW, Schellekens JM, Goeken LN (2003) Test-retest reliability of the Isernhagen Work Systems Functional Capacity Evaluation in patients with chronic low back pain. J Occup Rehabil 13:207–218
Gross DP, Battié MC (2003) Construct validity of a kinesiophysical functional capacity evaluation administered within a worker’s compensation environment. J Occup Rehabil 13:287–295
Roland M, Morris R (1983) A study of the natural history of low back pain: Part 1: development of a reliable and sensitive measure of disability in low-back pain. Spine 8:141–144
Brouwer S, Kuijer W, Dijkstra PU, Göeken LN, Groothoff JW, Geertzen JH (2004) Reliability and stability of the Roland Morris Disability Questionnaire: intra class correlation and limits of agreement. Disabil Rehabil 26:162–165
Farrar JT, Portenoy RK, Berlin JA, Kinman JL, Strom BL (2000) Defining the clinically important difference in pain outcome measures. Pain 88:287–294
Jensen MP, Karoly P (2001) Self-report scales and procedures for assessing pain in adults. In: Turk DC, Melzack R (eds) Handbook of pain assessment, 2nd edn. The Guilford Press, New York, pp 15–34
Arrindell WA, Ettema JHM (2003) Symptom Checklist. Handleiding bij een multidimensionele psychopathologie-indicator (Manual for a multidimensional psychopathology-indicator). (Dutch). Lisse: Swets Test Publishers
Vlaeyen JWS, Kole-Snijders AMJ, Boeren RG, van Eek H (1995) Fear of movement/(re)injury in chronic low back pain and its relation to behavioral performance. Pain 62:363–372
Vlaeyen JW, Geurts SM, Kole Snijders AMJ (1990) What do chronic pain patients think of their pain? Towards a pain cognition questionnaire. Brit J Clin Psychol 29:383–394
Schreurs PJG, Willige van de G, Brosschot JF, Tellegen B, Graus GMH (1993) De Utrechtse Coping Lijst: UCL. Omgaan met problemen en gebeurtenissen, herziene handleiding (The Utrecht’s Coping List: UCL. Managing problems and events, revised manual). (Dutch). Lisse: Swets Test Publishers
Spinhoven P, ter Kuile M, Kole-Snijders AMJ, Hutten Mansfeld M, den Ouden DJ, Vlaeyen JWS (2004) Catastrophizing and internal pain control as mediators of outcome in the multidisciplinary treatment of chronic low back pain. Eur J Pain 8:211–219
Lynch ME, Watson CPN (2006) The pharmacotherapy of chronic pain: a review. Pain Res Manage 11:11–38
Nijs J, Meeus M, van Oosterwijck J, Roussel N, de Kooning M, Ickmans K, Matic M (2011) Treatment of central sensitization in patients with “unexplained” chronic pain: what options do we have? Expert Opin Pharmacother 12:1087–1098
Acknowledgments
This work was partly supported by Grünenthal BV and Stichting Beatrixoord, The Netherlands. H.R. Schiphorst Preuper was the principal investigator.
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Trial Registration: EudraCT-number 2008-004227-39.
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Schiphorst Preuper, H.R., Geertzen, J.H.B., van Wijhe, M. et al. Do analgesics improve functioning in patients with chronic low back pain? An explorative triple-blinded RCT. Eur Spine J 23, 800–806 (2014). https://doi.org/10.1007/s00586-014-3229-7
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DOI: https://doi.org/10.1007/s00586-014-3229-7